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NCT Number: NCT05814237

POS-ARI-ER Observational Study of Acute Respiratory Infections

Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential, e.g. influenza and coronaviruses. The POS-ARI-ER study will focus on describing the different routine diagnostic and therapeutic practices in the work-up and treatment of ARI, as well as clinical outcomes across the patient population. In addition, POS-ARI-ER aims to characterise both the adult patient population with ARI presenting to acute hospital settings in Europe, and the aetiology of ARI in these patients.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasme Hospital, Brussels, Belgium

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About this study

The POS-ARI-ER study is a perpetual, observational study (POS), designed to provide data for clinical characterisation of acute respiratory infections (ARIs) in adults presenting to hospital settings across Europe.

Establishing the etiological cause of ARI at the time of presentation is difficult with currently available diagnostic approaches. Improvements in diagnosis and strategies for use of targeted antibiotic and antiviral treatment strategies are needed to improve patient outcomes, and to reduce selection of antimicrobial resistance (AMR) and antiviral resistance. Recent advances in routine diagnostics in secondary care settings include molecular tests that can detect multiple pathogens simultaneously, and highly sensitive and specific point of care tests that can provide attending clinicians with rapid results. However, the implementation of these technologies into routine clinical practice within hospitals, and any impact on treatment decisions or patient outcomes, has not been widely evaluated.

The aim is to accurately characterise cases of ARIs presenting to acute hospital services, such as emergency departments and acute medical assessment units, in Europe.

Characterisation will focus on identifying the routine diagnostic methods (laboratory and point of care testing) and pharmacological interventions employed by different centres in patients presenting with ARI. Data will be collected using standardised report forms that capture clinical, laboratory and prescribing information. Participants will include those who require admission to hospital, as well as patients who are discharged the same day from the emergency department or acute medical assessment unit. In addition, a subset of participants will have single upper respiratory tract research sample (e.g. nose/throat swab) obtained at enrolment (within 24 hours), for pathogen detection by molecular methods.

Describing the variations in routine practice provides a foundation both to improve patient care through currently available approaches, as well as to inform areas of focus for development of new strategies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Clinical suspicion of a new episode of acute respiratory tract infection, with onset in the last 10 days
  • Patient presents to an emergency room or secondary care setting
  • Informed consent is provided by patient or their legal representative

Exclusion criteria

  • Patient has been transferred from another hospital
  • Patient admitted to hospital for >2 days at the time of enrolment
  • Patient has been previously enrolled in the POS-ARI-ER study

Treatment and study plan

Data Collection

Other

Data collection from study participants to characterise diagnostic and therapeutic practices.

Primary outcomes

  1. Proportion of adult patients undergoing ARI-relevant microbiology and virology investigations.

    Time frame: Four years

    Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.

  2. Proportion of adult patients receiving antibiotics, antivirals, antifungals and/or immunomodulators.

    Time frame: Four years

    Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.

  3. Clinical outcome of adults with community acquired ARI in acute hospital settings in Europe.

    Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.

    Maximal score using the ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised.

  4. Length of hospital and/or ICU stay in adults with community acquired ARI in acute hospital settings in Europe.

    Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.

    Number of days patient admitted to hospital or ICU.

  5. Duration of NIV and IMV/ECMO in adults with community acquired ARI in acute hospital settings in Europe.

    Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.

    Number of days patients receiving NIV and IMV/ECMO.

  6. All cause mortality in adults with community acquired ARI in acute hospital settings in Europe.

    Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.

    Total number of deaths for each ARI-related pathogen.

Secondary outcomes

  1. Patient demographics of the adult patient population with ARI presenting to acute hospital settings in Europe.

    Time frame: Four years

    Evaluate demographics of patient population with ARI.

  2. Comorbidities in the adult patient population with ARI presenting to acute hospital settings in Europe.

    Time frame: Four years

    Evaluation of comorbidities in patient population with ARI.

  3. Presenting symptoms in the adult patient population with ARI presenting to acute hospital settings in Europe.

    Time frame: Four years

    Evaluation of presenting symptoms in the adult patient population with ARI.

  4. Physiological measurements in the adult patient population with ARI presenting to acute hospital settings in Europe.

    Time frame: Four years

    Evaluation of the physiological measurements in the adult patient population with ARI.

  5. Aetiology of ARI in adults presenting to acute hospital settings in Europe.

    Time frame: Four years

    Detection of putative pathogens in respiratory tract samples (research upper respiratory tract sample at presentation and ARI-relevant microbiology/virology results obtained through routine clinical care).

Other outcomes

  1. Association between clinical outcomes and diagnostic or treatment related variables, for different aetiologies of community acquired ARI in adults presenting to hospital across Europe.

    Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.

    Maximal score on ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised, stratified by pathogen.

Study contacts

Contact information is provided by the study sponsor or research team.

Yrene Themistocleous

CONTACT

[email protected]

01865 612979

Sponsors and collaborators

Lead sponsor

European Clinical Research Alliance for Infectious Diseases (ECRAID)

Other

Collaborators

  • UMC Utrecht
  • University of Oxford

Registry information

Official study title

Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings

Acronym: POS-ARI-ER

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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